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新鱼腥草素钠栓的制备及质量标准研究

Preparation and Quality Control of Sodium New Houttuyfonate Suppositories
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摘要 目的:制备新鱼腥草素钠栓剂,并建立其质量控制方法。方法:将新鱼腥草素钠制成直肠用栓,通过方法学考察建立了新鱼腥草素钠栓剂的质量控制体系结果:新鱼腥草素钠线性范围为10.01~100.10μg·ml^(-1)(r=0.999 6),平均回收率为99.81%(n=9),栓剂稳定性良好,质量可控结论:该栓剂制备工艺合理、稳定、可行,质量控制方法能较好的控制该制剂的质量。 Objective:To prepare sodium new houttuvfonate suppositories and establish the quality control standard.Method:The suppositories were prepared with sodium new houttuyfonate as the effective ingredient.According to the results of methodology,the quality control method was established.Result:There was a good linearity of sodium new houttuyfonate within the range of 10.01- 100.10μg· ml^(-1)(r = 0.999 6).The average recoveiy was 99.81%(n = 9 ).The suppositories were stable with promising dissolution. Conclusion:The preparation of the suppositories is reasonable,stable and practicable.The quality can be controlled by the eslablished quality standard.
作者 王海波 朱斌
出处 《中国药师》 CAS 2012年第12期1716-1718,共3页 China Pharmacist
关键词 新鱼腥草素钠 栓剂 制备 质量控制 Sodium new houttuyfonate Suppositories Preparation Quality control
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